Research Ethics Consorita Series

The Research Ethics Consortia series is a multi-disciplinary forum for investigators, institutional review board and research ethics committee members, students, fellows and faculty of Harvard University, the Center for Bioethics, and Harvard Catalyst.

Topics range from in-depth analysis of particular research protocols to broader discussions of the new and emerging trends in the theory and practice of research ethics and oversight.

Save the third Friday of the month for Research Ethics events.


Past Events

May 2019 Research Ethics Consortium

The Ethics of Conducting Studies Within A Trial (SWATs)

Thousands of clinical trials are conducted every year with the aim of improving the evidence base for medical practice. Yet, the evidence base for how best to conduct trials--making them as efficient and ethical as possible--is surprisingly thin.

Shaun Treweek, Chair in Health Services Research at University of Aberdeen, will discuss his efforts to promote the use of Studies Within A Trial (SWAT)-that is, folding a rigorous study about clinical trial best practices into a clinical trial itself.

Presenter:

Shaun Treweek, PhD, BSc (Hons)

Chair in Health Services Research

University of Aberdeen, Scotland

 

Commentator:

Christopher Gill, MD

Associate Professor, Global Health

Boston University

 

Moderator:

Bizu Gelaye, PhD, MPH

Teaching Faculty,

Center for Bioethics

Lecturer on Global Health and Social Medicine,

Harvard Medical School

Assistant Professor of Psychiatric Epidemiology

Harvard T.H. Chan School of Public Health

 

April 2019 Research Ethics Consortium

Advertising Clinical Trials in Oncology

Many medical centers advertise their clinical trials. In some cases, these advertisements suggest that trial participation may offer direct benefits to patients--a suggestion that conflicts with some of the foundational principles in research ethics.

Yet, recruitment remains one of the major challenges in conducting efficient clinical research and many patients are not aware of the trials for which they may be eligible. Therefore, advertising trials may be a good way to improve participation and help patients find trials.

In this month's Research Ethics Consortium, we will explore this ethical tension surrounding advertising clinical trials in oncology.

Presenters:

Jonathan Marron, MD, MPH

Instructor in Pediatrics

Dana-Farber Cancer Institute

Boston Children's Hospital Cancer and Blood Disorders Center

Research Fellow

Center for Bioethics

Harvard Medical School

 

Daniel Kronish, MD

Associate Director

Medical Review Office for Human Research Studies

Dana-Farber Cancer Institute

 

Moderator:

Spencer Phillips Hey, PhD

Faculty and Co-director of Research Ethics

Harvard Center for Bioethics

Research Scientist

Brigham and Women's Hospital

 

March 2019 Research Ethics Consortium

Science, Ethics, and Deception:

A study of medications, placebos, and labeling in acute episodic migraine

This month, Professor Ted Kaptchuk will present the results of a randomized control trial for patients with acute episodic migraines. The trial, conducted at the Beth Israel Deaconess Medical Center, provided a medication and an identical-appearing placebo intervention with the goal of assessing how medication labeling might modify their effects. In addition to raising familiar ethical issues around the use and study of placebos, this trial provoked significant ethical debate because it also involved deception.

Presenter:

Ted Kaptchuk

Professor of Global Health and Social Medicine, Professor of Medicine

Harvard Medical School

Director, Program in Placebo Studies & Therapeutic Encounter

Beth Israel Deaconess Medical Center

 

Commentator:

Benjamin Silverman, MD

IRB Chair Partners Human Research Committee

Partners HealthCare System

Instructor in Psychiatry

McLean Hospital

Faculty,

Center for Bioethics

Harvard Medical School

 

Moderator:

Bizu Gelaye, PhD, MPH

Research Ethics Co-Director, Harvard Center for Bioethics

Assistant Professor,

Harvard T. H. Chan School of Public Health, Harvard Medical School and

Division of Global Psychiatry, Massachusetts General Hospital

 

February 2019 Research Ethics Consortium

Should patients have control over their clinical research results?

This month, Brian Edlow will present his clinical trial, "Advanced MRI and EEG for Predicting Recovery of Consciousness after Severe Traumatic Brain Injury."

Given the potential implications for their future care or insurance, some patient-participants in this trial expressed a desire to not share their study results with their clinical team. But who has the right to decide what medically relevant information from a clinical trial can or cannot be shared with clinicians? Who is ultimately the authority on research data sharing? How should IRBs consider such requests, whether from researchers or patients, to restrict the flow of information from research to the clinical setting?

Presenters:
Brian L. Edlow, MD

Neurocritical Care Faculty, Massachusetts General Hospital

Associate Director,

Center for Neurotechnology and Neurorecovery

Director,

Laboratory for NeuroImaging of Coma and Consciousness

Affiliated Faculty,

Athinoula A. Martinos Center for Biomedical Imaging

Assistant Professor of Neurology, Harvard Medical School

 

Discussant:

Elizabeth Hohmann, MD

Associate Professor of Medicine/Infectious Diseases,

Physician Director and Chair, Partners Human Research Committee

Massachusetts General Hospital

 

Moderator:

Spencer Phillips Hey, PhD

Faculty and Co-director of Research Ethics,

Harvard Center for Bioethics

Research scientist,

Brigham and Women's Hospital

 

December 2018 Research Ethics Consortium

Exception from Informed Consent and the IMMEDIATE Trial

The IMMEDIATE Trial was a double-blind randomized controlled clinical effectiveness trial that evaluated the impact of intravenous glucose, insulin, and potassium for acute coronary syndromes patients. Since this intervention was administered by paramedics in the prehospital setting with a narrow therapeutic time window, it was granted an exception from informed consent (EFIC).

This month, we will discuss the ethical challenges involved in planning and conducting the IMMEDIATE Trial, and explore some of the broader patterns and ethical issues seen across EFIC trials more generally.

Presenter:

Joni Beshansky, LPD, MPH

Co-PI of the IMMEDIATE Trial

Associate Professor of Medicine

Tufts University School of Medicine Associate Professor

Regis College School of Health Sciences

Director, Regulatory Affairs and Clinical Research Graduate Program

 

Reviewer:

William Feldman, MD, DPhil

Fellow, Pulmonary and Critical Care Medicine

Brigham and Women's Hospital and Harvard Medical School

 

Moderator:

Bizu Gelaye, PhD, MPH

Research Ethics Co-Director, Harvard Center for Bioethics

Assistant Professor,

Harvard T. H. Chan School of Public Health, Harvard Medical School and

Division of Global Psychiatry, Massachusetts General Hospital

 

November 2018 Research Ethics Consortium

Ethical Issues in an Audit Method Study of Telemedicine

Studies that use audit method or "mystery-shopper technique" are widely used to understand the experiences of patients although they raise several ethical challenges. This month, we will discuss a study that uses an audit method where patients act as real patients buying birth control online from well known tele-birth control vendors. What are some of the ethical challenges surrounding the design and conduct of such a study?

Presenter:

Ateev Mehrotra, MD, MPH

Associate Professor Health Care Policy and Medicine, Harvard Medical School

Hospitalist, Beth Israel Deaconess Medical Center.

 

Reviewer:

Leslie Howes, MPH, CIP

Director, Office of Human Research Administration, Harvard Faculty of Medicine and Harvard T. H. Chan School of Public Health

 

Moderator:

Bizu Gelaye, PhD, MPH

Co-Director, Research Ethics, Harvard Center for Bioethics

Assistant Professor, Harvard T. H. Chan School of Public Health, Harvard Medical School and Division of Global Psychiatry, Massachusetts General Hospital

 

October 2018 Research Ethics Consortium

Is the Future of Clinical Cancer Research a Global Adaptive Trial?

Adaptive clinical trials are now mainstream science. This month, we will discuss the ethical implications of a new approach to cancer research, called "Global Cumulative Treatment Analysis" (GCTA), that takes adaptive trials to their logical conclusion-striving to optimize patient outcomes, trial efficiency, and cost by continuously integrating data collection, analysis, and decision making in a rapid learning loop. In the GCTA model, every patient is automatically a participant in a "global trial" that encompasses every plausible treatment regimen and test, and all available data is used to inform decisions at the point of care.

Presenters:

Jeff Shrager

Director of Research,

Cancer Commons

Adjunct Professor in Symbolic Systems,

Stanford University

 

Commentator:

Brian Alexander

Director,

Harvard-MIT Center for Regulatory Science

Associate Professor,

Radiation Oncology

Harvard Medical School

 

Moderator:

Spencer Hey

Faculty and Co-director of Research Ethics,

Harvard Center for Bioethics Research Scientist,

Brigham and Women's Hospital

 

September 2018 Research Ethics Consortium

Ethical Challenges of Phase 1 Clinical Trials

Research that involves phase I clinical trials raise particular ethical challenges, especially trials that involve novel therapies being tested in humans for the first time. This month, we will discuss ethical challenges around a phase 1 clinical trial in Rennes, France that resulted in the death of one person and the hospitalization of five others.

Presenters:

Spencer Hey, PhD

Co-Director, Research Ethics, Harvard Center for Bioethics

Research Fellow, Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women's Hospital

 

Joseph Cravero, MD

Senior Associate, Perioperative Anesthesia and Pain Medicine

Associate Professor of Anesthesia, Harvard Medical School

 

Commentator:

Barbara Bierer, MD

Faculty Director, Multi-Regional Clinical Trials Center, Harvard University

Professor of Medicine, Harvard Medical School

 

Moderator:

Bizu Gelaye, PhD

Co-Director, Research Ethics, Harvard Center for Bioethics

Assistant Professor, Division of Global Psychiatry, Massachusetts General Hospital

 

April 2018 Research Ethics Consortium

Open-label Placebo: Rationale, methods, data, and ethics

Open label placebo (OLP) - honestly prescribed placebos - is an emerging research agenda. The talk examines the ethical conundrum that led to this research, describes some OLP research, and analyzes accompanying ethical issues. The talk will focus on the first RCT published on OLP performed at the BIDMC. This study will be contrasted with more recent OLP studies in an effort to see the evolution of informed consent in OLP.

Study Documents:

1. Placebos without Deception: A Randomized Controlled Trial in Irritable Bowel Syndrome

2. Open-Label Placebo Treatment for Cancer-Related Fatigue: A Randomized-Controlled Clinical Trial

3. Are Open-Label Placebos Ethical? Informed Consent and Ethical Equivocations

Presenter:

Ted Kaptchuk

Professor of Global Health and Social Medicine, Professor of Medicine

Harvard Medical School

Director, Program in Placebo Studies & Therapeutic Encounter

Beth Israel Deaconess Medical Center

 

Commentator:

Laura Specker Sullivan

Post-doctoral Research Fellow

Center for Bioethics

Harvard Medical School

 

February 2018 Research Ethics Consortium

The 'Real World' of IRB Review:

Ethical and practical challenges in studying research ethics oversight

Through the process of ethical review, institutional review boards (IRBs) help to protect human subjects and uphold the integrity of the research enterprise. But how much do we actually know about the people, relationships, and practices that constitute the real world of IRB review? And how much do we need to know in order to judge whether IRBs are serving as good stewards of the research enterprise?

Eric Campbell, professor of medicine at Harvard Medical School and core faculty at the Mongan Institute for Health Policy, has conducted several studies examining conflicts of interest in the world of IRBs. In this consortium, he will present insights from this work and discuss some of the ethical and practical challenges in researching the people in charge of research ethics oversight.

Shannon Sewards, the director of IRB Administration for the Committee on the Use of Human Subjects at Harvard University, will provide commentary.

Presenter:

Eric G. Campbell, PhD

Teaching Faculty, Harvard Medical School Center for Bioethics

Faculty, Morgan Institute for Health Policy, Massachusetts General Hospital

 

Commentator:

Shannon Sewards, MA, CIP

Director of IRB Administration, Committee on the Use of Human Subjects, Harvard University

 

January 2018 Research Ethics Consortium

Can Researchers Predict the Outcome of Clinical Trials in Their Medical Specialty?

The quality and safety of clinical trials depend upon the ability of experts to make accurate predictions about the risks and likely benefits. However, we know very little about whether or not experts are actually good at making these risk/benefit predictions.

In this talk, Jonathan Kimmelman will describe a series of studies that he and his team at McGill University have conducted, which measured whether experts could accurately forecast the events, outcomes, and risks in trials. His findings suggest that although a subset of clinical experts show a high level of skill in predicting trial outcomes, most clinical experts under-perform simple prediction algorithms.

Presenters:

Jonathan Kimmelman, PhD

Associate Professor

Biomedical Ethics Unit/Social Studies of Medicine, McGill University

 

Commentator:

Mark Barnes, JD 

Faculty Co-director & Co-chair

Multi-Regional Clinical Trial (MRCT) Center, Brigham and Women's Hospital and Harvard Medical School

Partner, Ropes & Gray LLP

 

December 2017 Research Ethics Consortium

Keeping Good Patients Out of Bad Trials

The risks and costs of clinical trials are ethically justified by the promise of advances in scientific knowledge and the potential for benefits to future patients. However, many conducted trials are destined to provide no useful information because of issues in trial design, conduct, or reporting. These trials compete with potential useful studies for the same pool of research participants.

In this consortium, Deborah Zarin, the director of ClinicalTrials.gov, will examine these issues and discuss how the world's premier clinical trial registry can help stakeholders address this issue.

Paul McLean, a member of the Harvard Catalyst Research Subject Advocacy Board, and Luke Gelinas, senior researcher at the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics will provide commentary.

Presenters:

Deborah Zarin, MD

Director, 

Senior Scientist, National Institutes of Health

 

Commentators:

Paul McLean

Member, Harvard Catalyst Research Subject Advocacy Board

PCORI Co-Investigator, Governance of Learning Activities in Learning Healthcare Systems

 

Luke Gelinas, PhD, MA

Senior Researcher, Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics, Harvard Law School

 

November 2017 Research Ethics Consortium

Visualizing Data on Clinical Trials: Can It Help IRBs Fulfill Their Social Mission?

The focus of research ethics oversight tends to be on the properties of an individual protocol. However, some of the core judgments in ethics review --- such as a study's social and scientific value --- require that a protocol be evaluated in the context of the accumulating body of evidence and other ongoing research activities.

This month, presenters will demonstrate some new approaches for systematically visualizing data on clinical trials, and discuss ways in which these approaches may help research ethics committees to assess the value of a proposed study.

Presenters:

Spencer Hey, PhD

Faculty, Harvard Center for Bioethics

Research Scientist, Program on Regulation, Therapeutics, and Law (PORTAL)

 

Stephen Rosenfeld, MD

Executive IRB Chair, Quorum Review IRB, Chair, the Secretary's Advisory Committee for Human Research Protections (SACHRP)

 

Commentator:

Barbara E. Bierer, MD

Professor of Medicine, HMS

Faculty Co-Director, Multi-Regional Clinical Trials (MRCT) Center

Director, Regulatory Foundations, Ethics and the Law Program at Harvard Catalyst

 

October 2017 Research Ethics Consortium

The Role of the IRB in Quality Improvement and Human Subjects Research

When should a study be considered "quality improvement" (not requiring institutional review) and when should an institutional review board or research compliance officer be involved?

While many have tried to draw a sharp line between these two types of data gathering, there is little clear consistency and some projects fall in a gray area.

  1. month we will discuss an improvement survey on hospital culture of safety which generated subsequent interest around the secondary use of QI data for further research.

Principle Investigator:

Al Ozonoff, PhD, CPPS

Associate Professor of Pediatrics, Harvard Medical School

Director, Center for Applied Pediatric Quality Analytics, Boston Children's Hospital

 

Research Reviewer:

Susan Kornetsky, MPH

Director, Clinical Research Compliance, Boston Children's Hospital

 

Moderator:

Bizu Gelaye, PhD, MPH

Faculty Member, HMS Center for Bioethics

Research Scientist, Department of Epidemiology,

Harvard T.H. Chan School of Public Health

 

September 2017 Research Ethics Consortium

Ethical Issues in a Qualitative Study of Schizophrenia in Ethiopia

The prevalence of schizophrenia in Ethiopia appears to affect men at a rate of 5:1 over women - much higher than in other places. Where are the women with schizophrenia? A research study aimed to understand community members' cultural explanations of schizophrenia and improve cultural and gender sensitivity in identifying new patients with schizophrenia.

- How should such understandings be explored in a small rural area?

- What ethical concerns might arise in using community health workers to identify patients with schizophrenia?

- What are the ethical issues in using qualitative methodologies such as focus groups and individual interviews?

Principle Investigator:

Christina Borba, MPH, PhD

Director of Research, Department of Psychiatry, Boston Medical Center, Assistant Professor, BU School of Medicine

 

Commentator:

Bizu Gelaye, PhD

Faculty Member, HMS Center for Bioethics

Research Scientist, Harvard T.H. Chan School of Public Health